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C O M PA N Y
INTRODUCTION
Randox Laboratories Ltd. has over 20 years experience in the development, manufacture and marketing of high quality
diagnostic reagents and equipment for laboratory medicine. Randox supply circa 35,000 laboratories in over 130 countries
worldwide. All Randox reagents are manufactured under rigorous quality procedures to achieve the high quality standards
expected in clinical science. A significant proportion of resources are invested in research and development to ensure kits
are developed to the highest specifications and conform to international standards. Commitment to quality is emphasised
by ISO13485 accreditation for the development and manufacture of diagnostic test kits.
Randox’s clinical products can be found in almost every country. The Randox portfolio includes Biochip Array Technology,
clinical chemistry automation systems, external quality assurance schemes, Internet driven QA systems, quality control
materials, clinical reagents and environmental diagnostics.
Randox assayed and precision sera are available in human and bovine (only available in clinical chemistry controls) form.
Method-, temperature and instrument specific target values and ranges are available for all assayed sera. Randox
precision serum is supported with guideline values from a consensus mean of results from independent laboratories for
the most regular methods.
RIQAS
RIQAS, the external quality assessment scheme from Randox Laboratories is the world’s first clinical EQA scheme to gain
UKAS accreditation. The programme results and reports can be transmitted through postal, fax or e-transfer services.
RIQAS has been providing "Proficiency Testing Schemes" for laboratories worldwide for over 12 years. Today, RIQAS
offers 8 programmes with 160 analytes to circa 5000 participants in 59 countries. The 8 programmes currently available
include general clinical chemistry, specific proteins, therapeutic drugs, human urine, lipids, immunoassay, cardiac and
haematology.
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Randox have introduced a new internet-driven software package. The Peer Group reporting software utilises values from
laboratories worldwide and allows access to reports showing your analytical performance 24 hours a day, 7 days a week.
Designed to complement the Randox product range of control sera, a facilitates the monitoring of analytical
performance (internal quality control) and enables direct comparisons with laboratories worldwide (peer group reporting).
C O N T E N T S
Page
Number
MULTI CONTROLS
Cardiac Controls 7
CSF Controls 8
Immunoassay Controls 15
Lipid Controls 16
Specific Protein Controls 17
Therapeutic Drug Controls 18
Tumour Marker Control 19
Urine Assayed / Urine Precision Controls 20
MONO CONTROLS
Bilirubin Elevated / CRP / Fructosamine Controls 21
G-6-PDH / Glutathione & TAS Controls / HbA1c 22
Lipoprotein (a) / Microalbumin Urine Controls 23
Myoglobin / Ransel & Ransod Controls 24
Rheumatoid Factor Positive / Syphilis RPR/VDRL Controls 25
MULTI CALIBRATORS
Calibration Sera / Apolipoprotein A-1 & B Calibrators 26
CK-MB / Haemoglobin A1c / Hitachi™ Series Calibrators 27
IgE / Immunoglobulin ( ) / LDL & HDL-Cholesterol Calibrators 28
Specific Protein Calibrators (Liquid) / Therapeutic Drugs Calibrators 29
MONO CALIBRATORS
ASO / CRP 1 Point Liquid / CRP Multi Point Liquid Calibrators 30
Ferritin / Fructosamine / Glutathione Reductase Calibrators 31
Lipoprotein (a) / Microalbumin Calibrators 32
Myoglobin / Rheumatoid Factor Calibrators 33
STANDARDS
Mono and Multi Level Standards 34
RIQAS 35-36
Brochures & CD’s Available 37-38
SELECTING A CONTROL PRODUCT
Technology improvements in clinical pathology have revolutionised laboratory analysis by facilitating a
massive throughput of samples and the adaptation of the most up-to-date methodologies. Standardisation
and calibration of modern instruments play a pivotal role in the generation of quality information for accurate
clinical decision making. These developments have created a demand for a broad range of quality control
products to cover the ever-increasing list of tests carried out in clinical laboratories.
CONTROL MATRIX
Randox manufacture both human and bovine based control products for use in all laboratories. Lyophilised
controls are stable for up to 4 years after the date of manufacture.
Bovine-based sera is prepared from certified disease-free animal source material and offers high
performance for up to 44 clinical chemistry analytes when cost considerations are paramount.
Human-based sera is donor tested at source and found to be non-reactive for Hepatitis B and C antigen
and HIV I and II antibodies. Human-based sera offers a matrix consistent with human patient samples and
offers high performance for up to 70 analytes. It is generally preferred for immunological methods including
serum proteins and hormones.
All Randox control products are manufactured to the same high specifications using procedures recognised
by ISO 13485.
Unassayed serum is generally referred to as precision serum and is used only for the control of
reproducibility of results. Approximate values are assigned from a consensus mean of results from
independent laboratories for the most common method.
URINE CONTROLS
Values for assayed urine controls are assigned from a consensus of results from approximately 600
independent laboratories. Approximate values for unassayed urine controls are generated by results from
selected reference laboratories and assigned from 3 consensus of results obtained by these laboratories.
3 abc
COLOUR-CODED CONTROLS
Easy to use, colour-coded packaging will help distinguish between different levels and minimise costly
errors. Colour-coded bottles, caps and boxes will also aid stock management and usage of the products in
the laboratory. Colour-coded controls were introduced in 2003 however existing stocks will be in circulation
until 2007.
Level 1
Level 2
Level 3
Low
Medium
High
Blue
Green
Red
{ The descriptions, low, medium and high
are all generalisations. Some analytes will
fall outside these classifications.
LEVEL I
BOVINE LEVEL 2
ASSAYED LEVEL 3
LEVEL 2
HUMAN
LEVEL 3
CLINICAL CHEMISTRY
MULTI - SERA LEVEL I
BOVINE LEVEL 2
PRECISION LEVEL 3
LEVEL 2
HUMAN LEVEL 3
LEVEL 2
ASSAYED HUMAN
LEVEL 3
URINE CONTROLS
LEVEL 2
PRECISION HUMAN
LEVEL 3
LEVEL 2
CSF CONTROLS ASSAYED HUMAN LEVEL 3
LEVEL I
THERAPEUTIC DRUG CONTROLS ASSAYED HUMAN LEVEL 2
LEVEL 3
LEVEL I
IMMUNOASSAY LEVEL 2
CONTROLS ASSAYED HUMAN
LEVEL 3
LEVEL I
SPECIFIC PROTEIN LEVEL 2
ASSAYED HUMAN
CONTROLS
LEVEL 3
LEVEL I
LIPID CONTROLS ASSAYED HUMAN LEVEL 2
LEVEL 3
LEVEL I
CARDIAC CONTROLS ASSAYED HUMAN LEVEL 2
LEVEL 3
LEVEL I
TUMOUR MARKER CONTROLS ASSAYED HUMAN LEVEL 2
LEVEL 3
4
TM
Level 1
247 software is an internal quality control package for
247 Software on CD daily monitoring of laboratory performance. This
software can be run for the duration of the 60-day trial
at no cost to the customer. Cat. No. PR060
Level 2
Unregistered 247 software is valid for a trial period of
Registration to use 60 days. Software registration will re-activate the
software for unlimited use. 247 software upgrades are
247 software
available via a secure site at www.randox.com/247.
Users must register to gain access to the secure site.
Level 3
Customers can register to use the 247 peer group
Registration for Peer
programme for rapid upload and download of data at
Group licence the touch of a button. Cat. No. QC4201
TEXT ON TUTORIAL
Randox has recently developed an educational tutorial to assist all new users of the 247 software. Our free
interactive 247 tutorial contains explicit instructions, for example, on how to set up the data panels, enter
results, run reports and upload results via the Internet. The tutorial contains an online help manual to
ensure that the client always has access to a solution on any problem or query they may have.
Each user of the tutorial will have a unique username and password; a laboratory manager can then view
the progress of each member of staff as frequently as they wish. At the end of each section in the tutorial
there is a self-assessment exercise that allows all users to test their knowledge and understanding of the
247 software programme.
This multi-lingual tutorial will be provided on each individual 247 software disc.
a
™
delivers ...
• INTERNET-DRIVEN SOFTWARE with peer group values from laboratories worldwide
• DATA VALIDATION user-defined selection criteria
• MULTILEVEL PASSWORDS for system security
• RAPID DATA ENTRY by user-defined panels and tests
• LEVEY-JENNINGS AND HISTOGRAM PLOTS for internal analysis
• PEER GROUP DATA updated every 24 hours
• GROUP CO-ORDINATOR REPORTS
• EASY TO LOAD SOFTWARE
• FREE INSTRUCTION MANUAL provided on software CD and 247 website
• PARTICIPANT PERFORMANCE SUMMARY CHARTS for peer group comparisons
• ONSCREEN DISPLAY of laboratory results and peer group statistics
• FLEXIBLE SERUM COMBINATION
• PEER GROUP DATA automatically downloaded on the upload of laboratory QC data
• PEER GROUP STATISTICS worldwide and laboratory groups
The 247 tutorial and online help manual have been designed to help users perform tasks within the 247 system.
The interactive tutorial allows the user to test their understanding of the 247 software program.
It is recommended that the user reads the relevant section of the manual whilst they are completing a section of the tutorial.
All analytes can be entered during the user-defined QC test set-up process.
New analytes can then be added as required by following the same process.
Ordering Information
Product Description Size Cat No.
Tri-level Cardiac Control 3 x 1ml CQ3100
7 multi
CSF Controls
Human Assayed Control
for the control of up to seven components and five electrophoresis regions at two levels.
Analytes
Chloride, Glucose, IgG, Lactic acid, Sodium, Total Protein (Coomassie Blue), Total Protein (Pyrogallol Red).
Electrophoresis - Albumin, α-1-globulin, α-2 globulin, β-globulin, γ-globulin.
Features
• Human-based product.
• Lyophilised material.
• Target values and ranges quoted for components.
• % Total Protein quoted for electrophoresis.
• Compatible for use on most clinical analysers.
Stability
• Lyophilised material stable to expiry.
• After reconstitution the controls are stable for 2 days @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
CSF Control Level 2 10 x 3ml CF1500
CSF Control Level 3 10 x 3ml CF1501
multi 8
GENERAL CLINICAL CHEMISTRY
Bovine Assayed Serum
offers high quality lyophilised product for 44 clinical chemistry parameters at three levels.
Analytes
Electrolytes Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous,
Potassium, Sodium, Zinc.
Enzymes Acid Phosphatase Prostatic, Acid Phosphatase Total, Alkaline Phosphatase, ALT,
Amylase Total, AST, CK Total, γ-GT, GLDH, α-HBDH, LDH, Lipase.
Substrates Bilirubin Direct, Bilirubin Total, Creatinine, D-3-Hydroxybutyrate, Glucose, Urea, Uric Acid.
Others Bile Acids, Cortisol, Total T4, Free T4, T3, Osmolality, TIBC.
Features
• Bovine-based product.
• Lyophilised material.
• Method-, Instrument- and Temperature-specific values provided.
• Analyte range quoted.
• Compatible for use on most clinical analysers.
Stability
• Lyophilised material stable to expiry.
• Reconstituted stability of 7 days @ +2°C to +8°C, and one month when stored @ -20°C.
(Refer to characteristic sheet for exceptions)
Ordering Information
Product Description Size Cat No.
Bovine Assayed Multisera Level 1 20 x 5ml AL1027
Bovine Assayed Multisera Level 2 20 x 5ml AN1026
Bovine Assayed Multisera Level 3 20 x 5ml AE1032
9 multi
GENERAL CLINICAL CHEMISTRY
Bovine Precision Serum
offers a high quality lyophilised product for 43 clinical chemistry parameters at three levels.
Analytes
Electrolytes Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous,
Potassium, Sodium, Zinc.
Enzymes Acid Phosphatase Prostatic, Acid Phosphatase Total, Alkaline Phosphatase, ALT,
Amylase Total, AST, CK Total, γ-GT, GLDH, α-HBDH, LDH, Lipase.
Substrates Bilirubin Direct, Bilirubin Total, Creatinine, D-3-Hydroxybutyrate, Glucose, Urea, Uric Acid.
Others Bile Acids, Cortisol, Total T4, Free T4, T3, Osmolality, TIBC.
Features
• Bovine-based product.
• Lyophilised material.
• Approximate values quoted for most common method.
• Variety of vial sizes to suit the needs of all laboratories.
• Compatible for use on most clinical analysers.
Stability
• Lyophilised material stable to expiry.
• Reconstituted stability of 7 days @ +2°C to +8°C, and one month when stored @ -20°C.
(Refer to characteristic sheet for exceptions)
Ordering Information
Product Description Size Cat No.
Bovine Precision Multisera Level 1 20 x 5ml SL1084
Bovine Precision Multisera Level 1 12 x 10ml SL1097
Bovine Precision Multisera Level 2 20 x 5ml SN1085
Bovine Precision Multisera Level 2 12 x 10ml SN1098
Bovine Precision Multisera Level 3 20 x 5ml SE1086
Bovine Precision Multisera Level 3 12 x 10ml SE1099
multi 10
GENERAL CLINICAL CHEMISTRY
Human Assayed Serum
offers a quality lyophilised product for 70 clinical chemistry parameters at two levels.
Analytes
Drugs Digoxin, Gentamycin, Paracetamol (Acetaminophen), Salicylate, Theophylline,
Tobramycin.
Enzymes Acid Phosphatase Prostatic, Acid Phosphatase Total, Aldolase, Alkaline Phosphatase,
ALT, Amylase Total, Amylase Pancreatic, AST, Butyryl Cholinesterase, CK Total, γ-GT,
GLDH, α-HBDH, LAP, LDH, Lipase.
Proteins Albumin, Apolipoprotein A-1, Apolipoprotein B, IgA, IgG, IgM, Protein Total, PSA,
Transferrin.
Others Bile Acids, Cortisol, Folate, Total T4, Free T4, T3, Osmolality, TIBC, TSH, Vitamin B 12.
Features
• Lyophilised material, 100% Human matrix.
• Method-, Instrument- and Temperature-specific values provided.
• Analyte range provided.
• Reference method values offered are with particular lots for calcium, chloride, cholesterol, creatinine,
glucose, lithium, magnesium, potassium, total protein, sodium, triglycerides and uric acid.
• Variety of pack sizes to suit the needs of all laboratories.
• Compatible for use on most clinical analysers.
Stability
• Lyophilised material stable to expiry.
• Reconstituted stability of 7 days @ +2°C to +8°C, and one month when stored @ -20°C.
(Refer to characteristic sheet for exceptions)
Ordering Information
Product Description Size Cat No.
Human Assayed Multisera Level 2 5 x 5ml HN2612
Human Assayed Multisera Level 2 20 x 5ml HN1530
Human Assayed Multisera Level 3 5 x 5ml HE2613
Human Assayed Multisera Level 3 20 x 5ml HE1532
Human Assayed Multisera Level 2 & 3 5 x 5ml HS2611
11 multi
GENERAL CLINICAL CHEMISTRY
Human Precision Serum
offers a high quality lyophilised product for 70 clinical chemistry parameters at two levels.
Analytes
Drugs Digoxin, Gentamycin, Paracetamol (Acetaminophen), Salicylate, Theophylline,
Tobramycin.
Enzymes Acid Phosphatase Prostatic, Acid Phosphatase Total, Aldolase, Alkaline Phosphatase,
ALT, Amylase Total, Amylase Pancreatic, AST, Butyryl Cholinesterase, CK Total, γ-GT,
GLDH, α-HBDH, LAP, LDH, Lipase.
Proteins Protein Total, PSA, Albumin, Apolipoprotein A-1, Apolipoprotein B, IgA, IgG, IgM,
Transferrin.
Others Bile Acids, Cortisol, Folate, Total T4, Free T4, T3, Osmolality, TIBC, TSH, Vitamin B 12.
Features
• Lyophilised material, 100% Human matrix.
• Approximate target values are provided for most common analytes and method.
• Variety of vial sizes to suit the needs of all laboratories.
• Compatible for use on most clinical analysers.
Stability
• Lyophilised material stable to expiry.
• Reconstituted stability of 7 days @ +2°C to +8°C, and one month when stored @ -20°C.
(Refer to characteristic sheet for exceptions)
Ordering Information
Product Description Size Cat No.
Human Unassayed Multisera Level 2 20 x 5ml UN1557
Human Unassayed Multisera Level 2 12 x 10ml UN1562
Human Unassayed Multisera Level 3 20 x 5ml UE1558
Human Unassayed Multisera Level 3 12 x 10ml UE1559
multi 12
IMMUNOASSAY Controls
Human Assayed
sera available in three levels for the control of accuracy and precision for up to 31 analytes.
Features
• Human-based product.
• Lyophilised material.
• Combined control includes thyroid hormones, fertility hormones and tumour markers.
• Very low TSH levels in level 1 allowing assessment of assay sensitivity.
• Instrument-specific values provided.
• Analyte range quoted.
• Compatible for use on most clinical analysers.
Stability
• Lyophilised product stable to expiry.
• Reconstituted stability of 7 days @ +2°C to +8°C, 4 weeks @ -20°C.
Ordering Information
Product Description Size Cat No.
Immunoassay Control Level 1 10 x 5ml IA2638
Immunoassay Control Level 2 10 x 5ml IA2639
Immunoassay Control Level 3 10 x 5ml IA2640
Tri-level Immunoassay Control 12 x 5ml IA2633
15 multi
LIPID Controls
Human Assayed Sera
for the control of up to seven lipid parameters at three levels.
Features
• Human-based sera.
• Lyophilised material.
• Target value and range quoted.
• Compatible for use on most clinical analysers.
Stability
• Lyophilised material stable to expiry.
• Stable for 1 month @ -20°C when frozen once.
Ordering Information
Product Description Size Cat No.
Lipid Control Level 1 5 x 1ml LE2668
Lipid Control Level 1 5 x 3ml LE2661
Lipid Control Level 2 5 x 1ml LE2669
Lipid Control Level 2 5 x 3ml LE2662
Lipid Control Level 3 5 x 1ml LE2670
Lipid Control Level 3 5 x 3ml LE2663
multi 16
SPECIFIC PROTEIN Controls
Human Assayed Sera
human-based assayed sera available in three levels for the control of accuracy and precision for up to
25 analytes.
Features
• Liquid sera.
• Human-based product.
• Method-specific values.
• Analyte range quoted.
• Compatible for use on most clinical analysers.
Stability
• Stable for up to 2 years after the date of manufacture.
Ordering Information
Product Description Size Cat No.
Specific Protein Control Level 1 3 x 1ml PS2682
Specific Protein Control Level 2 3 x 1ml PS2683
Specific Protein Control Level 3 3 x 1ml PS2684
17 multi
THERAPEUTIC DRUG Controls
Human Assayed Sera
Drug controls sera available in three levels for the control of accuracy and precision for up to 18 analytes.
Features
• Human-based product.
• Lyophilised material.
• Method-specific values provided.
• Analyte range quoted.
• Compatible for use on most clinical analysers.
Stability
• Lyophilised product stable to expiry.
• Reconstituted stability of 4 weeks @ -20°C.
Ordering Information
Product Description Size Cat No.
Drug Control Level 1 20 x 5ml HD1667
Drug Control Level 2 20 x 5ml HD1668
Drug Control Level 3 20 x 5ml HD1669
multi 18
TUMOUR MARKER Control
Human Assayed Sera
for the control of up to 16 tumour markers at three levels.
Analytes
Alpha foetoprotein (AFP)
β-2-Microglobulin Analyte values are method specific,
CA 19-9 please request kit insert for details.
CA 125
CA 15-3
Carcinoembryonic Antigen (CEA)
Cyfra 21
Ferritin
Free PSA
Human Chorionic Gonadotrophin (HCG)
Neuron Specific Enolase (NSE)
Prostatic Acid Phosphatase (PAP)
Prolactin
PSA-ACT
Tissue Polypeptide Antigen (TPA)
Total PSA
Features
• Human-based, liquid sera.
• Target value and range quoted.
• Compatible for use on most clinical analysers.
Stability
• Stable to expiry date when stored @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
Tri-Level Tumour Marker Control 9 x 2ml IA2679
19 multi
URINE ASSAYED Controls
human-based material available in two levels for the control of accuracy and precision for up to 23 analytes.
Analytes
Albumin, Calcium, Chloride, Copper, Cortisol, Creatinine, Dopamine, Epinephrine, Glucose,
5-Hydroxy-indole acetic acid, Magnesium, Metanephrine, Norepinephrine, Normetanephrine, Osmolality,
Oxalate, Inorganic Phosphorous, Potassium, Total Protein, Sodium, Urea, Urate, Vanillylmandelic acid.
Features
• Lyophilised material.
• Human-based product.
• Method-specific values provided.
• Target value and range quoted.
• Compatible for use on most clinical analysers.
Stability
• Lyophilised material stable to expiry.
• After reconstitution the controls are stable for 5 days @ +2°C to +8°C or 14 days @ -20°C.
(Refer to characteristics sheet for exceptions)
Ordering Information
Product Description Size Cat No.
Urine Assayed Control Level 2 12 x 10ml AU2352
Urine Assayed Control Level 3 12 x 10ml AU2353
Analytes
Calcium, Chloride, Creatinine, Glucose, Magnesium, Phosphorous, Potassium, Sodium, Urea, Urate.
Features
• Lyophilised material.
• Human-based product.
• Approximate values quoted.
• Compatible for use on most clinical analysers.
Stability
• Lyophilised material stable to expiry.
• After reconstitution the controls are stable for 5 days @ +2°C to +8°C or 14 days @ -20°C.
Ordering Information
Product Description Size Cat No.
Urine Unassayed Control Level 2 10 x 10ml UC1502
Urine Unassayed Control Level 3 10 x 10ml UC1503
multi 20
BILIRUBIN (Elevated)
Assayed Serum
offers control for samples with elevated bilirubin levels (total and direct values quoted).
Analytes Total Bilirubin, Direct Bilirubin
Features
• Bovine-based serum.
• Lyophilised material.
• Method-specific values.
• Target values and ranges quoted.
Stability
• Lyophilised material stable to expiry.
• Stable for 24 hours @ +2°C to +8°C after reconstitution when protected from light.
Ordering Information
Product Description Size Cat No.
Bilirubin Elevated Control 10 x 3ml BE454
Stability
• Stable to expiry date when stored @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
CRP Liquid Control Level 2 10 x 1ml CP2480
CRP Liquid Control Level 3 10 x 1ml CP2481
S CRP High Sensitivity Control Level 1 10 x 1ml CP2476
S CRP High Sensitivity Control Level 2 10 x 1ml CP2477
S Liquid
FRUCTOSAMINE Controls
Analyte Fructosamine
Features
• Lyophilised material.
• Two control levels.
Stability
• Stable to expiry date when stored @ +2°C to +8°C.
• Reconstituted components are stable for 28 days @ +2°C to +8°C, and 28 days @ -20°C.
Ordering Information
Product Description Size Cat No.
Fructosamine Control Level 1 3 x 1ml FR2994
Fructosamine Control Level 3 3 x 1ml FR2996
21 mono
G-6-PDH Controls
Human Assayed Haemolysate
for the control of G-6-PDH (Glucose-6-phosphate dehydrogenase)
Analyte G-6-PDH
Features
• Human-based whole blood.
• Lyophilised material.
• Target value and range quoted.
Stability
• Lyophilised product stable to expiry when stored @ +2°C to +8°C.
• Stable for 7 days @ +2°C to +8°C after reconstitution.
Ordering Information
Product Description Size Cat No.
G-6-PDH Control Deficient 6 x 0.5ml PD2617
G-6-PDH Control Normal 6 x 0.5ml PD2618
Features
• Target values and ranges quoted.
• Controls compatible for use on most clinical analysers.
Stability
• Controls are stable to expiry when stored @ +2ºC to +8ºC.
• Glutathione Reductase has a reconstituted stability of 1 day @ +2ºC to +8ºC.
• TAS control has a reconstituted stability of 2 days @ +2ºC to +8ºC.
Ordering Information
Product Description Size Cat No.
Glutathione Reductase Control 10 x 5ml GR2608
Total Antioxidant Status Control 10 x 5ml NX2331
HbA1c / Hb
Analyte Haemoglobin A1c
Features
• Liquid product.
• Two control levels.
• Reconstitution fluid provided.
Stability
• Stable to expiry date when stored @ +2°C to +8°C.
• Reconstituted controls stable for 3 months @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
HbA1c / Hb Level 1 & 2 2 x 0.25ml HA3445
mono 22
LIPOPROTEIN (a) Control
Analytes Lp(a)
Features
• Human-based product.
• Lyophilised material.
Stability
• Unreconstituted controls are stable to expiry.
• After reconstitution the control is stable for 14 days @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
Lipoprotein (a) Control Level 3 3 x 1ml LP3406
Stability
• Lyophilised material stable to expiry @ +2°C to +8°C.
• After reconstitution the controls are stable for 5 days @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
Microalbumin Urine Control Level 1 10 x 1ml MA1411
Microalbumin Urine Control Level 3 10 x 1ml MA1412
23 mono
MYOGLOBIN Control
Assayed Control
for the control of myoglobin levels in immunoturbidimetric based methods.
Analyte Myoglobin
Features
• Lyophilised material.
• Target value and range quoted.
• Suitable for Immunoturbidimetric methods.
Stability
• Lyophilised material stable to expiry when stored @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
Myoglobin Control Level 2 & 3 4 x 3ml MY2490
mono 24
RHEUMATOID FACTOR POSITIVE Control
Human Assayed Serum
latex enhanced immunoturbidimetric assays.
Analyte Rheumatoid Factor
Features
• Liquid ready to use.
• Target value and range quoted.
Stability
• Stable to expiry date when stored @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
Rheumatoid Factor Positive Control 5 x 1ml RF2302
25 mono
CALIBRATORS
Randox manufacture calibration sera for a range of clinical chemistry analysers.
CALIBRATION SERA
Human-based material is available in two levels for the calibration of clinical analysers, offering values for
up to 39 parameters. All calibration sera is human based lyophilised serum and component concentrations
are available at two levels. Calibration sera is distributed to 3000 laboratories and values are assigned from
a concensus of results obtained by these laboratories.
Analytes
Electrolytes- Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous,
Osmolality, Potassium, Sodium, Zinc.
Enzymes- Acid Phosphatase Total, Acid Phosphatase Prostatic, Alkaline Phosphatase, Alanine
Transaminase, Amylase, Pancreatic Amylase, Aspartate Transaminase, Cholinesterase,
Creatine Kinase, Gamma Glutamyl Transferase, GLDH, Hydroxybutyrate Dehydrogenase,
Lactate Dehydrogenase.
Lipids- Cholesterol, Triglycerides.
Proteins- Albumin, Total Protein.
Substrates - Bile acids, Bilirubin Total, Bilirubin Direct, Creatinine, D-3-Hydroxybutyrate, Glucose,
Lactate, TIBC, Urea, Uric acid.
Features
• Human-based product.
• Lyophilised material.
• Instrument, Method and Temperature specific values quoted.
• Compatible for use on most clinical analysers.
Stability
• Lyophilised material stable to expiry @ +2°C to +8°C.
• After reconstitution the calibrators are stable for 7 days @ +2°C to +8°C and 4 weeks @ -20°C.
(See characteristic sheet for exceptions)
Ordering Information
Product Description Size Cat No.
Calibration Sera Level 2 20 x 5ml CAL2350
Calibration Sera Level 3 20 x 5ml CAL2351
multi 26
CK-MB Calibrator
Analytes CK-MB, Total CK
Features
• Lyophilised material.
• Human-based product.
• Compatible for use on most clinical analysers.
Stability
• Lyophilised material stable to expiry @ +2°C to +8°C.
• After reconstitution the calibrator is stable for 5 days @+2°C to +8°C.
Ordering Information
Product Description Size Cat No.
CK-MB Calibrator 10 x 1ml CK2393
Features
• Liquid ready to use product.
• Values quoted for six levels.
Stability
• Stable to expiry date when stored @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
HbA1c / Hb Calibrator 5 x 2ml, 1 x 8ml HA3444
Ordering Information
Product Description Size Cat No.
Hitachi™ Series Calibrator 10 x 3ml HC2314
27 multi
IgE Calibrator Set
Analytes IgE
Features
• Human-based product.
• Lyophilised material.
• 6 level calibrator.
Stability
• Stable to expiry date when stored @ +2°C to +8°C.
• Stable for four weeks @ +2°C to +8°C after reconstitution.
Ordering Information
Product Description Size Cat No.
IgE Calibrator Set 6 x 1ml IE2492
IMMUNOGLOBULIN Calibrator ( )
Analytes IgA, IgG, IgM
Features
• Ready to use liquid.
• For use with immunoglobulin assays.
Stability
• Stable to expiry.
• Open vials are stable for 30 days @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
Immunoglobulin Calibrator ( ) 3 x 1ml IT3861
multi 28
SPECIFIC PROTEIN Calibrator (Liquid)
For use with samples that DO NOT require pre-dilution
Analytes ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG,
IgM, IgE, Prealbumin, Transferrin.
Features
• Ready to use liquid.
Stability
• Stable to expiry date when stored @ +2°C to +8°C.
• Open vials are stable for 30 days @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
Specific Protein Calibrator (Liquid) 6 x 1ml IT2691
29 multi
ASO Calibrator
(Latex enhanced Immunoturbidimetric)
Analyte ASO
Features
• Ready to use liquid.
• Human-based product.
• Compatible for most clinical analysers.
Stability
• After opening calibrators are stable up to expiry @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
ASO Calibrator 5 x 1ml LO2306
Ordering Information
Product Description Size Cat No.
CRP Calibrator (1 Point Liquid) 3 x 1ml CP2178
mono 30
FERRITIN Calibrator
Analyte Ferritin
Features
• Ready to use liquid.
• Human-based product.
• Compatible for most clinical analysers.
• Multi-level calibrator.
Stability
• Stable to expiry date when stored @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
Ferritin Calibrator Series 6 x 1ml FN2491
FRUCTOSAMINE Calibrator
Analyte Fructosamine
Features
• Lyophilised material.
Stability
• Stable to expiry date when stored @ +2°C to +8°C.
• Stable for 28 days @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
Fructosamine Calibrator 3 x 1ml FR2993
31 mono
LIPOPROTEIN (a) Calibrator Series
Analytes Lp(a)
Features
• Lyophilised material.
• Five levels.
Stability
• Stable to expiry date when stored @ +2°C to +8°C.
• Reconstituted components are stable for 14 days @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
Lipoprotein (a) Calibrator 5 x 1ml LP3404
Features
• Ready to use liquid.
• Human-based product.
• Compatible for most clinical analysers.
• Multi-level Calibrator.
Stability
• Calibrators are stable to expiry when stored @ +2°C to +8°C.
Ordering Information
Product Description Size Cat No.
Microalbumin Calibrator Series 6 x 2ml MA1567
mono 32
MYOGLOBIN Calibrator
Analyte Myoglobin
Features
• Lyophilised material.
• Compatible for use on most clinical analysers.
• Multi-level calibrator.
Stability
• Lyophilised material stable to expiry.
Ordering Information
Product Description Size Cat No.
Myoglobin Calibrator 4 x 1ml MY2456
33 mono
STANDARDS
34
RIQAS
I N F O R M A T I O N I S P O W E R
RIQAS Programmes
RIQAS has been providing "Proficiency Testing Schemes" for laboratories worldwide for over 12
years. Today, RIQAS offers 8 programmes with 160 analytes to circa 4500 participants in 60
countries around the world.
RIQAS is a dynamic, user-led scheme, which recognises that laboratory requirements vary
significantly and therefore offers a flexible programme choice. With a combined total of 60 years
EQA experience, the RIQAS team are in an excellent position to offer quality EQA solutions. RIQAS
is continuously developing new programmes and innovative software for EQA.
e-transfer
At present, the user-friendly, charted reports allow interpretation of
performance ‘at a glance’. To advance this service, software trials are in
progress for the electronic transfer of results and reports. This will reduce the
turn around time and cut down significantly on the amount of ‘paperwork’. It
will also make it much easier to implement method changes.
UKAS Accreditation
RIQAS, the external quality assessment scheme from Randox Laboratories is the
world’s first clinical EQA scheme to gain UKAS accreditation.
The United Kingdom Accreditation Service is the sole national accreditation
body recognised by government to assess, against internationally agreed
standards, organisations that provide certification, testing, inspection and
calibration services*. The RIQAS EQA scheme has been recognised by the UK
accreditation body UKAS for providing a first class inter laboratory comparison
assessment service. 0010 PT
35
Programme Options
RIQAS RQ9110
GENERAL CLINICAL CHEMISTRY PROGRAMME
REFERENCE METHOD VALUES
41 Analytes, weekly samples
2 x 6 monthly cycles
12 months subscription
36
Brochures & CD’s Available from
37
Lipase Lipoprotein (a) Microalbumin Powerline... Product
the electronic Profile
library
To order brochures and CD’s or if you require any further information email: marketing@randox.com 38
®
International Headquarters
Randox Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY
Tel: +44 (0) 28 9442 2413, Fax: +44 (0) 28 9445 2912, E-Mail Address: marketing@randox.com
www.randox.com
Italia Kyrgyzstan
Magyarország
Randox Laboratories Ltd. Randox Laboratories
Randox Laboratories Ltd.
Via Casale Ferranti, 5 Microrayon, Building 57, Apartment 53,
Magyarorszagi Kereskedelmi Kepviseleti
35/C 00173 Roma RM, Italia. Bishkek, Kyrgyzstan, Central Asia.
Irodaja, H-1029 Budapest,
Tel: +39 06 721 53 72 Tel: +996 312 582 678
Honfoglalás u. 40. C8, Hungary.
Fax: +39 06 721 53 76 Fax: +996 312 478 059
Tel/Fax: +36 1 275 7964